- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01492452
The Anxiety of Parents of Children Undergoing Cardiac Surgery
December 14, 2011 updated by: Instituto de Cardiologia do Rio Grande do Sul
Standard Guidelines Impact of Nursing Anxiety of Parents of Children Undergoing Cardiac Surgery: Randomized Clinical Trial
This is a randomized clinical trial.
The population consisted of parents of children undergoing cardiac surgery from December 2010 to April 2011.
We included parents aged over 18 years, and the following were considered exclusion criteria: inability to understand and/or answer the questions for any reason, parents of children undergoing surgery for insertion of the pacemaker and defibrillator, surgical death and not take up the case.
22 parents in the intervention group were randomized and received standardized guidelines for nursing and 22 parents participated in the control group received the guidelines and routine of the institution.
Anxiety was assessed using the STAI State-Trait Inventory in the preoperative period and 48 hours after surgery the child.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
anxiety
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- We included parents aged over 18 years
Exclusion Criteria:
- inability to understand and/or answer the questions for any reason,
- parents of children undergoing surgery for insertion of the pacemaker and defibrillator,
- surgical death and not take up the case
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: guidelines
22 parents in the intervention group were randomized and received standardized guidelines for nursing:The guidelines took around an hour and involved pre-operative care such as bathing with detergent solution, pre-anesthetic administration (as prescribed), preoperative fasting (as prescribed), clothing, hygiene care and nail oral.
They were also provided information on the endotracheal tube, tubes, catheters, epicardial pacemaker wires and electrodes to be used in the perioperative period and which remain for some period after surgery, as well as possible complications.
|
Information was provided regarding the preoperative preparation of the child, the same conditions and in the postoperative period, as well as information relating to housing and food for the parents.
The conventional orientation took about 15 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety inventory
Time Frame: five months
|
STAI State-Trait Inventory
|
five months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: M A Moraes, Phd, Institute of Cardiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
December 13, 2011
First Submitted That Met QC Criteria
December 14, 2011
First Posted (Estimate)
December 15, 2011
Study Record Updates
Last Update Posted (Estimate)
December 15, 2011
Last Update Submitted That Met QC Criteria
December 14, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP4555/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.